The delay for phase III resusts of glufosamide mean nothing one way or the other according to the press release. The results will not be known at least until the end of February. There's really not a whole lot working for THLD right now until maybe after 2007. I hate it when they say they expect topline results because those were their exact words for TH-070 and we know now that those were just bogus remarks. I have a hard time putting much weight on anything they say. This may be a huge bust also. MW
I have two quetions.Someone please let me know, 1.(about)300 pations are in the trial.Is that means 150 are with placebo and 150 are with Glufosfamide? 2.Does placebo,in this trial,mean BSC(=best supportive care)? Is that like the following explanation mentioned?
(The following is from THLD web) Phase 3 Trial Details The phase 3 trial will evaluate approximately 300 previously-treated patients with metastatic pancreatic cancer who receive glufosfamide (4500mg/m2) once every 3 weeks or best supportive care (BSC). Best supportive care includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells.
To clarify, "topline results" simply means whether the trial met the primary endpoint for success. Every trial has a designated primary measurement for success - with respect to the Phase III trial, this is "overall survival", which will be measured from the time of treatment to death -i.e. if those treated with Glufo on average survive longer. The trial also has a number of secondary endpoints or measurements (alternative measures of effectiveness and safety), which typically are not disclosed until a later date.